FDA Approves Pemfexy (pemetrexed for injection) as a Branded Alternative to Alimta
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE) February 10, 2020 --Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the“Company”) today announced that it has received final approval from the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 11, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine
HOLLY SPRINGS, N.C., Feb. 3, 2020 /PRNewswire/ -- Seqirus, a global leader in influenza prevention and pandemic response, today announced that the U.S. Food and Drug Administration (FDA) has approved Audenz™ (Influenza A (H5N1) Monovalent... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 3, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] as First Treatment for Peanut Allergy
BRISBANE, Calif.--(BUSINESS WIRE)--Jan. 31, 2020-- Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that the U.S. Food... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 31, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Monoferric (ferric derisomaltose) Injection for the Treatment of Iron Deficiency Anemia
MORRISTOWN, N.J., Jan. 29, 2020 /PRNewswire/ -- Pharmacosmos Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Monoferric® (ferric derisomaltose) injection 100 mg/mL. ... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 29, 2020 Category: Drugs & Pharmacology Source Type: news

Teva Announces FDA Approval of Ajovy (fremanezumab-vfrm) Injection Autoinjector
PARSIPPANY, N.J.--(BUSINESS WIRE) January 28, 2020 -- Teva Pharmaceuticals USA, Inc. an affiliate ofTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Food and Drug Administration (FDA) has approved an autoinjector... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 28, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Trijardy XR (empagliflozin/linagliptin/metformin) for Type 2 Diabetes in Adults
RIDGEFIELD, Conn., and INDIANAPOLIS, Jan. 27, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) to lower blood sugar in adults with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 28, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Merck ’s Dificid (fidaxomicin) to Treat Clostridioides difficile in Children Aged Six Months and Older
KENILWORTH, N.J.--(BUSINESS WIRE)-- Monday, January 27, 2020 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Dificid... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 27, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tazverik (tazemetostat) for the Treatment of Patients with Epithelioid Sarcoma
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 23, 2020-- Epizyme, Inc. (Nasdaq: EPZM), a biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 23, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)
DUBLIN--(BUSINESS WIRE)--Jan. 21, 2020-- Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved Tepezza (teprotumumab-trbw) for the treatment of Thyroid Eye Disease (TED). Tepezza is the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 21, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ozempic (semaglutide) for Cardiovascular Risk Reduction in Adults with Type 2 Diabetes and Known Heart Disease
PLAINSBORO, N.J., Jan. 16, 2020 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Ozempic (semaglutide) injection 0.5 mg or 1 mg to reduce the risk of major adverse... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 16, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Numbrino (cocaine hydrochloride) Nasal Solution for Nasal Anesthesia
PHILADELPHIA, Jan. 13, 2020 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA), submitted under the 505(b)(2) regulatory... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 13, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Valtoco (diazepam nasal spray) as a Seizure Rescue Treatment
SAN DIEGO, CA– January 13, 2020– Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Valtoco (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 13, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ayvakit (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor
CAMBRIDGE, Mass., Jan. 9, 2020 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 9, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Indication of Mycamine (micafungin for injection) for the Treatment of Invasive Candidiasis in Pediatric Patients Less Than 4 Months of Age
NORTHBROOK, Ill., Jan. 8, 2020 /PRNewswire/ -- Astellas Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Mycamine (micafungin for injection) in support of the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 8, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
KENILWORTH, N.J.--(BUSINESS WIRE) January 8, 2020 --Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 8, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Fiasp (insulin aspart injection) for the Treatment of Children with Diabetes
PLAINSBORO, N.J., Jan. 6, 2020 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Fiasp (insulin aspart injection) 100 u/mL for use as a new mealtime insulin option for children with diabetes.1... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 6, 2020 Category: Drugs & Pharmacology Source Type: news

Lynparza (olaparib) Approved in the US as a First-Line Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer
30 December 2019 -- AstraZeneca and Merck& Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that Lynparza® (olaparib) has been approved in the US for the maintenance treatment of adult patients... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 30, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients
December 23, 2019 -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito,“Eisai”) today announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for its in-house discovered and developed orexin... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 23, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Caplyta (lumateperone) for the Treatment of Schizophrenia in Adults
NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Caplyta (lumateperone)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 23, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ubrelvy (ubrogepant) for the Acute Treatment of Migraine
DUBLIN, Dec. 23, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Ubrelvy (ubrogepant) for the acute treatment of migraine with or without... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 23, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens
20 December 2019 -- AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has approved Enhertu® (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 20, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Conjupri (levamlodipine maleate) for the Treatment of Hypertension
Hong Kong, 20 December 2019 -- The board of directors (the“Board”) of CSPC Pharmaceutical Group Limited (the“Company”, together with its subsidiaries, the“Group”) is pleased to announce that Conjupri®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 20, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ervebo (Ebola Zaire Vaccine, Live) for the Prevention of Disease Caused by Zaire Ebolavirus
KENILWORTH, N.J.--(BUSINESS WIRE) December 20, 2019 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Ervebo® (Ebola Zaire Vaccine, Live)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 19, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Arazlo (tazarotene) Lotion for the Topical Treatment of Acne Vulgaris
BRIDGEWATER, N.J., Dec. 19, 2019 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the U.S. Food... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 19, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Padcev (enfortumab vedotin-ejfv) for Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer
TOKYO and BOTHELL, Wash., Dec. 18, 2019 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 18, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parenteral Nutrition (TPN)
DUBLIN, Ireland, Dec. 16, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced today that the U.S. Food and Drug Administration (FDA) has approved Nouress (AV001), a cysteine hydrochloride injection, a critical drug for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 16, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN)
DUBLIN, Ireland, Dec. 16, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced today that the U.S. Food and Drug Administration (FDA) has approved Nouress (AV001), a cysteine hydrochloride injection, a critical drug for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 16, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xtandi (enzalutamide) for the Treatment of Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
NEW YORK& TOKYO--(BUSINESS WIRE)--December 16, 2019 -- Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.,“Astellas”) announced today that the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 16, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vascepa (icosapent ethyl) to Reduce Cardiovascular Risk
DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 13, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication and label expansion for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 13, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves EluRyng (etonogestrel/ethinyl estradiol vaginal ring), the First Generic NuvaRing
BRIDGEWATER, N.J.--(BUSINESS WIRE) December 12, 2019 -- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the“Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 12, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xeljanz XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis
December 12, 2019 - Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 12, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vyondys 53 (golodirsen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 53
CAMBRIDGE, Mass., Dec. 12, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Vyondys 53™... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 12, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Avsola (infliximab-axxq), a Biosimilar to Remicade
THOUSAND OAKS, Calif., Dec. 6, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Avsola (infliximab-axxq) for all approved indications of the reference product, Remicade®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 6, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for The Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
South San Francisco, CA -- December 3, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 3, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves RediTrex (methotrexate) for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, and Psoriasis
NASHVILLE, Tenn., Dec. 2, 2019 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for RediTrex, its new... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 2, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Oxbryta (voxelotor) for the Treatment of Sickle Cell Disease
November 25, 2019 -- Today, the U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.“Today’s... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 25, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Exservan (riluzole) Oral Film for the Treatment of Amyotrophic Lateral Sclerosis
WARREN, N.J., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products to solve therapeutic problems, today announced that... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 25, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xcopri (cenobamate) for the Treatment of Partial-Onset Seizures in Adults
PANGYO, South Korea and PARAMUS, N.J., Nov. 21, 2019 /PRNewswire/ -- SK Biopharmaceuticals, Co., Ltd., an innovative global pharmaceutical company focused on developing and bringing treatments to market for central nervous system (CNS) disorders,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 21, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Calquence for Adults with Chronic Lymphocytic Leukemia
21 November 2019 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1 The... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 21, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Givlaari (givosiran) for Acute Hepatic Porphyria
CAMBRIDGE, Mass.--(BUSINESS WIRE) November 20, 2019 --Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved Givlaari (givosiran) injection for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 20, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Abrilada (adalimumab-afzb), a Biosimilar to Humira
November 18, 2019 - Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Abrilada™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),1 for the treatment of certain... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 18, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Adakveo (crizanlizumab-tmca) to Reduce Frequency of Pain Crises in Individuals Living with Sickle Cell Disease
Basel, November 15, 2019– Novartis announced today that the US Food and Drug Administration (FDA) approved Adakveo (crizanlizumab), previously known as SEG101, to reduce the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 15, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Fetroja (cefiderocol) for the Treatment of Complicated Urinary Tract Infections
November 14, 2019 -- The U.S. Food and Drug Administration today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 14, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Brukinsa (zanubrutinib) for the Treatment of Mantle Cell Lymphoma
CAMBRIDGE, Mass. and BEIJING, China, Nov. 14, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 14, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Reblozyl (luspatercept-aamt) for the Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions
SUMMIT, N.J.& CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced the U.S. Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt) for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 9, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta
Holzkirchen, Nov. 5, 2019– Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar Ziextenzo (pegfilgrastim-bmez). Sandoz biosimilar pegfilgrastim... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 5, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Talicia (omeprazole magnesium, amoxicillin and rifabutin) for the Treatment of H. pylori Infection in Adults
TEL-AVIV, Israel and RALEIGH, N.C., Nov. 04, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the“Company”), a specialty biopharmaceutical company primarily focused... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 4, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Fluzone High-Dose Quadrivalent (Influenza Vaccine) for Adults 65 Years of Age and Older
PARIS, Nov. 4, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for Fluzone High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older. Fluzone... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 4, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vumerity (diroximel fumarate) for Multiple Sclerosis
CAMBRIDGE, Mass. and DUBLIN, Ireland, Oct. 30, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) approved Vumerity (diroximel fumarate), a novel oral... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 30, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Liletta (levonorgestrel-releasing intrauterine system) to Prevent Pregnancy for up to Six Years
SAN FRANCISCO and DUBLIN October 28, 2019– Medicines360, a global nonprofit organization with a mission to expand women’s access to quality medicines, and Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced that... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 28, 2019 Category: Drugs & Pharmacology Source Type: news